Kidney DysfunctionPhase 1NCT02840812
Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Severe Impaired Renal Function
A Phase 1 study testing Nemonoxacin in people with Kidney Dysfunction, run by Zhejiang Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a single center, open-label, non-randomized, 1:1 parallel control and single dose administration study design. Healthy subjects will be matched to severe renal function impaired (eGFR≤30mL/min/1.73m2，CKD-EPI estimated) subjects in age, gender and weight as parallel control, which matches healthy with normal… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Dysfunction
- What is being tested?
- Nemonoxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2017to Jan 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with kidney impairment
- male or female aged 18 to 70 years；
- has a body mass index of 17 to 30 kg/m2;
- Patients with severe impaired renal function or end-stage renal disease (eGRF≤30ml/min/1.73m2, CKD-EPI estimated),and don't have hemodialysis.
- Female volunteers must meet:
- Has sterilization operation, or who are postmenopausal must have been postmenopausal for >1 year, or
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- Has childbearing potential, but meet the requirement as following:
- Negative pregnancy test prior to enrollment, and Agree with use 1 medical accepted methods of birth control (eg. Hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) during the whole study and continuing until 1 month after the end of the study, and Non-breastfeeding;
- Male volunteers must agree to use medical accepted method of birth control (e.g. barrier contraceptive or sexual partner use the method as (4) above) during the study and through 1month after the end of study；
- Agree stay in ward prior to dosing within 48h, and agree not to take coffee, tea, chocolate, alcohol, grapefruit juice, orange juice and other food and drink which contain caffeine and xanthine；
- Can sign informed consent form on his own accord；
- Can comply with study procedures.
- Healthy subjects without renal impairment
- Male or female volunteers (matched to a subject with renal impairment in gender）；
- Aged 18 to 70 years (matched to a subject with renal impairment±5 years, matched range cannot exceed±5 years)；
- Has a body mass index of 17 to 30 kg/m2（matched to a subject with hepatic impairment±15%，matched range cannot exceed±15%）；
- Must be in good health as determined by screening medical history, physical examination, vital signs, laboratory test, B ultrasonography and chest X ray；
- Renal function is normal (eGFR≥90mL/min/1.73m2)
- Female volunteers must meet:
- Has sterilization operation, or who are postmenopausal must have been postmenopausal for >1 year, or
- Has childbearing potential, but meet the requirement as following:
- Negative pregnancy test prior to enrollment, and Agree with use 1 medical accepted methods of birth control (eg. Hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) during the whole study and continuing until 1 month after the end of the study, and Non-breastfeeding;
- Male volunteers must agree to use medical accepted method of birth control (e.g. barrier contraceptive or sexual partner use the method as (6) above) during the study and through 1month after the end of study；
- Agree stay in ward prior to dosing within 48h, and agree not to take coffee, tea,chocolate, alcohol, grapefruit juice, orange juice and other food and drink which contain caffeine and xanthine；
- Can sign informed consent form on his own accord；
- Can comply with study procedures
Who cannot join
- Subjects with kidney impairment
- Has known or suspected allergies to quinolones, fluoroquinolones,Nemonoxacin or excipients or allergic constitution；
- Has diseases (e.g. unstable cardiac disease, uncontrolled hypertension, uncontrolled asthma, uncontrolled diabetes, uncontrolled thyroid disease, uncontrolled epilepsy, myasthenia gravis or other neuromuscular disease, which may affect PK profile of drug in vivo or increase the risk in study except the disease caused renal function impaired;
- Has moderate or severe anemia (Hb<60g/L), severe hypertension (SBP>180mmHg and/or DBP>110mmHg) or diabetic nephropathy;
- Has history of clinically significant cardiovascular, neurological or psychiatric, gastrointestinal, pulmonary, renal, endocrine disease prior to study within 1 year；
- Has disease seriously affect the immune system such as hematological disease, malignant tumor, or taking immunosuppressant；
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- Scr changes exceed more than 30% compared with baseline (Renal function tests two weeks before screening period ,even not conducted in this study can performed as baseline);
- Has uracratia or anuria;
- Has significant drug change including prescription drugs, non-prescription drugs or nutritional regimen 2 weeks before dosing(judged by investigator);
- Has administration of drug which eliminated mainly via kidney or damage kidney 2 weeks before dosing or need combination use in the study (e.g. TMP-SMZ or non-steroid anti-inflammatory drug);
- Has a history of alcoholism within 2 years prior to dosing; drink≥12 times within 3 months prior dosing; alcohol test positive as screening；
- Has history of drug misuse within 2 years prior to dosing; urine drug screen positive；
- Has history of taking products of tobacco or nicotine more than 5 cigarettes/day within 1 month prior to dosing, or cannot stop smoking during the study;
- Use of another investigational drug or drug which can damage hepatic function within 3 months prior to dosing；
- Has history of blood donation 3 months before study;
- Use of drugs affect function of liver metabolism enzyme (e.g. benzene, isopropyl amine, the barbiturates benzodiazepines, marijuana, cocaine, opiates and phencyclidine) within 30 days prior to dosing；
- Has to take the drug which may affect the PK profile of investigate drug (e.g. antacids, sucralfate, metal cation, calcium supplements, warfarin, nonsteroidal anti-inflammatory drugs, theophylline, cyclosporine, probenecid and cimetidine)；
- Has gastrointestinal disease or malabsorption syndrome affecting drug Absorb；
- Has history of seizures or central nervous system disease which the investigator considers to interfere with compliancy of protocol; or has risk of suicide；
- Clinical significant abnormal 12-lead electrocardiograms (ECGs) at screening (eg. atrioventricular block, torsades de pointes ventricular tachycardia (TdT), and other types of ventricular tachycardia, ventricular fibrillation, ventricular flutter, T wave change with clinical significance or any abnormal results of 12-lead ECG which affect QTc interphase)；
- HIVAb, HBsAg, HCVAb or syphilis RPR test positive;
- Not agree stay in ward prior to dosing within 48h, and agree not to take coffee, tea,chocolate, alcohol, grapefruit juice, orange juice and other food and drink which contain caffeine and xanthine；
- Conditions investigator consider not suitable to be enrolled in the study.
- Healthy subjects without kidney impairment
- Has known or suspected allergies to quinolones, fluoroquinolones, nemonoxacin or excipients or allergic constitution；
- Has a history of alcoholism within 2 years prior to dosing; drink≥12 times within 3 months prior dosing; alcohol test positive as screening；
- Has history of drug misuse within 2 years prior to dosing; urine drug screen positive；
- Has history of taking products of tobacco or nicotine more than 5 cigarettes/ day within 1 month prior to dosing, or cannot stop smoking during the study；
- Donated blood or use of another investigational drug within 3 months prior to dosing；
- Has history of chronic liver, renal, cardiovascular, neurological or psychiatric, gastrointestinal, pulmonary, urinary, endocrine disease cannot controlled by drugs；
- Use of drugs affect function of liver metabolism enzyme within 30 days prior to dosing; or need to take medications which may affect the PK profile of investigational drug (including: products containing Calcium, aluminum, magnesium, iron and zinc, sucralfate, antacid, nutrition supplements, Vitamins and metal supplements) during the study；
- Is taking any antibacterial agents；
- HIV-Ab, HBsAg ,HCV-Ab or syphilis RPR positive；
- Clinical significant abnormal 12-lead electrocardiograms (ECGs) at screening (eg. atrioventricular block, torsades de pointes ventricular tachycardia (TdT), and other types of ventricular tachycardia, ventricular fibrillation, ventricular flutter, T wave change with clinical significance or QTc>450ms) ；
- Has abnormal result of laboratory test with clinical significance assessed by investigator at screening；
- Has gastrointestinal disease or malabsorption syndrome affecting drug Absorb；
- Has history of seizures or central nervous system disease which the investigator considers to interfere with compliancy of protocol; or has risk of suicide；
- Has any antibacterials, glucocorticoids, immunosuppressive agents or drug may damage organs within 14 days prior to dosing；
- Cannot orally take drug；
- Has history of or currently has disease and condition may affect the safety and efficancy assessment of investigational drug judged by investigator；
- Conditions investigator consider not suitable to be enrolled in the study;
- Is a member of the clinical site personnel directly affiliated with this study；
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ZheJiang Medicine
Shaoxing
Wei Mao, ＋86 575-86026539, maow@xcpharma.com
Jing Zhang, Doctor
About this study
This is a single center, open-label, non-randomized, 1:1 parallel control and single dose administration study design. Healthy subjects will be matched to severe renal function impaired (eGFR≤30mL/min/1.73m2，CKD-EPI estimated) subjects in age, gender and weight as parallel control, which matches healthy with normal renal function according to the of subjects with impaired renal function as, after enrollment of subjects with severe impaired renal function (eGFR≤30mL/min/1.73m2，CKD-EPI estimated). Renal function impaired group and control group both receive orally single-dose of nemonoxacin malate capsule (0.5g). Collect the blood and urine samples before and after the administration to perform pharmacokinetic analysis and safety observation.
Read the detailed description
Single dose study: evaluate safety and tolerability of oral nemonoxacin capsule 500mg
- Conditions
- Kidney Dysfunction
- Being tested
- Nemonoxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NemonoxacinDrug
Also called Nemonoxacin Malate Capsules
Nemonoxacin Malate Capsules 500mg single dose oral
| Study group | Role | What they receive |
|---|---|---|
| Renal function impaired | Experimental | Subject with Severe Impaired Renal Function. Nemonoxacin Malate Capsules 500mg single dose oral Receives: Drug: Nemonoxacin |
| Healthy Subjects | Experimental | Healthy volunteers. Nemonoxacin Malate Capsules 500mg single dose oral. Receives: Drug: Nemonoxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function:maximum plasma drug concentration ( Cmax)
Measured: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: time at which maximum plasma concentration is observed (Tmax)
Measured: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: area under the plasma concentration vs. time curve (AUC0-t and AUC0-∞)
Measured: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: elimination half-life (t1/2)
Measured: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: mean dissolution time(MRT)
Measured: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: total clearance of the drug from plasma (CLz/F)
Measured: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: Apparent Volume of Distribution (Vz/F)
Measured: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: cumulative amount of unchanged drug excreted into the urine (Ae Urine 0-24h,0-72h）
Measured: Within 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function::renal clearance of the drug from plasma (CLr)
Measured: Within 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function:minimum plasma drug concentration (Cmin)
Measured: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing]
Secondary outcomes (8)
Safety assessed by AEs
reported spontaneously or not by leading questions
Measured: up to 72 hours after study drug dosing
Safety assessed by vital signs-respiratory rate
respiratory rate, "times per minute"
Measured: up to 72 hours after study drug dosing
Safety assessed by vital signs-body temperature
body temperature, "degree centigrade"
Measured: up to 72 hours after study drug dosing
Safety assessed by vital signs-blood pressure
blood pressure, "mmHg"
Measured: up to 72 hours after study drug dosing
Safety assessed by vital signs-pulse rate
pulse rate, "beats per minute"
Measured: up to 72 hours after study drug dosing
Number of Participants with Abnormal Laboratory Values
Hematology, blood biochemistry,cogulation test and urinalysis
Measured: up to 72 hours after study drug dosing
Safety assessed by physical examination
(1) general appearance (2) skin (3) head and neck (4)chest, including heart, pulmonary and breast (5) abdomen, including stomach and intestines, liver and gallbladder (6) back (7) Urinary tract (8) extremity (9) neurological or psychiatric system (10) lymph gland (11)others.
Measured: up to 72 hours after study drug dosing
Safety assessed by 12-lead ECGs
Measured: up to 72 hours after study drug dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start5 Apr 2017
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840812
- Sponsor's protocol ID
- XCNN-150830-2
- Status last verified
- Apr 2018
- First submitted
- 19 Jul 2016
- Last updated
- 3 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Severe Impaired Renal Function
- ClinicalTrials.gov ID
- NCT02840812
- Acronym / sponsor ID
- XCNN-150830-2
- Conditions
- Kidney Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Zhejiang Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center, open-label, non-randomized, 1:1 parallel control and single dose administration study design. Healthy subjects will be matched to severe renal function impaired (eGFR≤30mL/min/1.73m2，CKD-EPI estimated) subjects in age, gender and weight as parallel control, which matches healthy with normal renal function according to the of subjects with impaired renal function as, after enrollment of subjects with severe impaired renal function (eGFR≤30mL/min/1.73m2，CKD-EPI estimated). Renal function impaired group and control group both receive orally single-dose of nemonoxacin malate capsule (0.5g). Collect the blood and urine samples before and after the administration to perform pharmacokinetic analysis and safety observation.
Detailed description
Single dose study: evaluate safety and tolerability of oral nemonoxacin capsule 500mg
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal function impaired | Experimental | Drug: NemonoxacinSubject with Severe Impaired Renal Function. Nemonoxacin Malate Capsules 500mg single dose oral |
| Healthy Subjects | Experimental | Drug: NemonoxacinHealthy volunteers. Nemonoxacin Malate Capsules 500mg single dose oral. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Subjects with kidney impairment
- Negative pregnancy test prior to enrollment, and Agree with use 1 medical accepted methods of birth control (eg. Hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) during the whole study and continuing until 1 month after the end of the study, and Non-breastfeeding;
- Healthy subjects without renal impairment
- Negative pregnancy test prior to enrollment, and Agree with use 1 medical accepted methods of birth control (eg. Hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) during the whole study and continuing until 1 month after the end of the study, and Non-breastfeeding;
Key exclusion criteria (42 listed)
- Subjects with kidney impairment
- Healthy subjects without kidney impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NemonoxacinAlso: Nemonoxacin Malate CapsulesNemonoxacin Malate Capsules 500mg single dose oral | Drug | Healthy Subjects, Renal function impaired |
Primary outcome
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function:maximum plasma drug concentration ( Cmax)
Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: time at which maximum plasma concentration is observed (Tmax)
Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: area under the plasma concentration vs. time curve (AUC0-t and AUC0-∞)
Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: elimination half-life (t1/2)
Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: mean dissolution time(MRT)
Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: total clearance of the drug from plasma (CLz/F)
Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: Apparent Volume of Distribution (Vz/F)
Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: cumulative amount of unchanged drug excreted into the urine (Ae Urine 0-24h,0-72h）
Time frame: Within 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function::renal clearance of the drug from plasma (CLr)
Time frame: Within 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function:minimum plasma drug concentration (Cmin)
Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing]
8 secondary outcomes
Safety assessed by AEs
Time frame: up to 72 hours after study drug dosing
Safety assessed by vital signs-respiratory rate
Time frame: up to 72 hours after study drug dosing
Safety assessed by vital signs-body temperature
Time frame: up to 72 hours after study drug dosing
Safety assessed by vital signs-blood pressure
Time frame: up to 72 hours after study drug dosing
Safety assessed by vital signs-pulse rate
Time frame: up to 72 hours after study drug dosing
Number of Participants with Abnormal Laboratory Values
Time frame: up to 72 hours after study drug dosing
Safety assessed by physical examination
Time frame: up to 72 hours after study drug dosing
Safety assessed by 12-lead ECGs
Time frame: up to 72 hours after study drug dosing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nemonoxacin in people with Kidney Dysfunction, run by Zhejiang Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function:maximum plasma drug concentration ( Cmax) (time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.